药品名称BENDECTIN
申请号010598产品号002
活性成分DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE市场状态停止上市
剂型或给药途径TABLET, EXTENDED RELEASE;ORAL规格10MG;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构SANOFI AVENTIS US LLC
化学类型New combination审评分类Standard review drug
与本品相关的专利信息(来自橙皮书Orange Book)
专利号专利过期日是否化合物专利是否产品专利专利用途代码专利下载
历史专利信息
与本品相关的市场独占权保护信息
独占权代码失效日期
历史市场独占权保护信息
与药品注册相关的信息
申请号修订号审批结论公开文档类型文档创建时间获取文档
药品注册审批历史信息
申请号修订号审批结论审批日期审批内容
010598014AP1982/12/09Package Change
010598013AP1982/09/07Labeling Revision
010598012AP1982/06/16Control Supplement
010598011AP1981/10/22Labeling Revision
010598010AP1981/10/22Labeling Revision
010598009AP1981/01/09Labeling Revision
010598008AP1979/11/06Formulation Revision
010598007AP1979/07/25Manufacturing Change or Addition
010598006AP1978/11/01Expiration Date Change
010598005AP1978/08/01Labeling Revision
010598003AP1976/11/09Labeling Revision
010598002AP1976/11/09General Efficacy (MarkIV)
010598000AP1956/07/30Approval